Access and closure device and method

ABSTRACT

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make a steep and controlled access path into a vascular lumen is disclosed. Methods for using the device are also disclosed.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to the field of accessing a biologicallumen and closing the access port thereby created.

2. Description of the Related Art

A number of diagnostic and interventional vascular procedures are nowperformed translumenally, where a catheter is introduced to the vascularsystem at a convenient access location—such as the femoral, brachial, orsubclavian arteries—and guided through the vascular system to a targetlocation to perform therapy or diagnosis. When vascular access is nolonger required, the catheter and other vascular access devices must beremoved from the vascular entrance and bleeding at the puncture sitemust be stopped.

One common approach for providing hemostasis is to apply external forcenear and upstream from the puncture site, typically by manualcompression. This method is time-consuming, frequently requiringone-half hour or more of compression before hemostasis. This procedureis uncomfortable for the patient and frequently requires administeringanalgesics. Excessive pressure can also present the risk of totalocclusion of the blood vessel, resulting in ischemia and/or thrombosis.

After hemostasis is achieved by manual compression, the patient isrequired to remain recumbent for six to eighteen hours under observationto assure continued hemostasis. During this time bleeding from thevascular access wound can restart, potentially resulting in majorcomplications. These complications may require blood transfusion and/orsurgical intervention.

Bioabsorbable fasteners have also been used to stop bleeding. Generally,these approaches rely on the placement of a thrombogenic andbioabsorbable material, such as collagen, at the superficial arterialwall over the puncture site. This method generally presents difficultylocating the interface of the overlying tissue and the adventitialsurface of the blood vessel. Implanting the fastener too far from thedesired location can result in failure to provide hemostasis. If,however, the fastener intrudes into the vascular lumen, thrombus canform on the fastener. Thrombus can embolize downstream and/or blocknormal blood flow at the thrombus site. Implanted fasteners can alsocause infection and auto-immune reactions/rejections of the implant.

Suturing methods are also used to provide hemostasis after vascularaccess. The suture-applying device is introduced through the tissuetract with a distal end of the device located at the vascular puncture.Needles in the device draw suture through the blood vessel wall onopposite sides of the punctures, and the suture is secured directly overthe adventitial surface of the blood vessel wall to close the vascularaccess wound.

To be successful, suturing methods need to be performed with a precisecontrol. The needles need to be properly directed through the bloodvessel wall so that the suture is well anchored in tissue to provide fortight closure. Suturing methods also require additional steps for thesurgeon.

Due to the deficiencies of the above methods and devices, a need existsfor a more reliable vascular closure method and device. There alsoexists a need for a vascular closure device and method that does notimplant a foreign substance and is self-sealing. There also exists aneed for a vascular closure device and method requiring no or few extrasteps to close the vascular site.

BRIEF SUMMARY OF THE INVENTION

A device for accessing a biological lumen is disclosed. The biologicallumen has a lumen wall having a longitudinal lumen wall axis. The devicehas an elongated member that has a longitudinal member axis. The memberis configured to access the lumen at a first angle. The first angle isdefined by the longitudinal lumen wall axis and the longitudinal memberaxis. The first angle is less than about 19 degrees.

The first angle can be less than about 15 degrees. The first angle canbe less than about 10 degrees. The device can also have an anchor. Theanchor can be configured to hold the elongated member at a fixed anglewith respect to the longitudinal lumen wall axis.

The device can also have a retainer. The retainer can be configured tohold the elongated member at a fixed angle with respect to thelongitudinal lumen axis.

Another device for accessing a biological lumen is disclosed. Thebiological lumen has a lumen wall and a longitudinal lumen wall axis.The device has a first elongated member and a second elongated member.The first elongated member has a first elongated member axis. The secondelongated member has a second elongated member axis. The secondelongated member is configured so that the second elongated member axisis parallel to the longitudinal lumen wall axis.

The second elongated member can have a retainer. The retainer can havean inflatable member. The retainer can have a resilient member. Thesecond elongated member can extend substantially adjacent to the lumenwall.

Also disclosed is a device for closing an opening on a biological lumenwall. The device has a longitudinal axis, a first force-applying member,a second force-applying member, and a resilient member. The resilientmember provides to the first and the second force-applying members aforce that is radially outward with respect to the longitudinal axis.

A method of accessing a blood vessel through a blood vessel wall is alsodisclosed. The blood vessel wall has a longitudinal wall axis. Themethod includes entering the vessel at an angle of less than about 19degrees with respect to the longitudinal wall axis. The method alsoincludes inserting a lumenal tool into the vessel.

Also disclosed is a method for accessing a biological lumen. Thebiological lumen has a lumen wall and a longitudinal lumen wall axis.The method includes inserting in the biological lumen a second elongatedmember. The second elongated member has a second elongated member axis.The method also includes aligning the second elongated member so thatthe second elongated member axis is substantially parallel to thelongitudinal lumen wall axis. Further, the method includes inserting inthe biological lumen a first elongated member comprising a firstelongated member axis.

Additionally disclosed is a method of closing a vascular opening. Thevascular opening has an inside surface and a longitudinal axis. Themethod includes inserting a device in the opening and applying a forceto the inside surface. The force is directed in at least one radiallyoutward direction from the longitudinal axis.

The method can include maintaining the force. The applying a force caninclude the device applying at least a part of the force. The applyingof a force can include the device applying all of the force.

Also disclosed is a method for accessing and closing a blood vesselhaving a vessel wall. The vessel wall can have an inside surface and anoutside surface. The method includes forming an arteriotomy anddeploying a closure augmentation device in the arteriotomy. The closureaugmentation device produces pressure on the inside surface and theoutside surface.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of an embodiment of the arteriotomydevice.

FIG. 2 is a side view of the arteriotomy device of FIG. 1.

FIG. 3 is a close-up view of the arteriotomy device of FIG. 1.

FIGS. 4 and 5 are close-up views of various embodiments of the anchor.

FIG. 6 is a side perspective view of an embodiment of the arteriotomydevice with the introduction device deployed.

FIG. 7 is a close-up view of an embodiment of the arteriotomy devicewith the introduction device deployed.

FIGS. 8 and 9 are side views of various embodiments of the arteriotomydevice with the introduction devices deployed.

FIG. 10 is a bottom perspective view of an embodiment of the arteriotomydevice.

FIG. 11 is a side view of an embodiment of the arteriotomy device withthe lumenal retainer deployed.

FIG. 12 is a bottom perspective view of an embodiment of the arteriotomydevice with the lumenal retainer deployed.

FIG. 13 is a side perspective view of an embodiment of the arteriotomydevice.

FIG. 14 is a side perspective view of an embodiment of the arteriotomydevice with the entry wall retainer deployed.

FIGS. 15 and 16 illustrate various embodiments of the tensioner.

FIGS. 17 and 18 illustrate various embodiments of the pressure clip.

FIGS. 19 and 20 illustrate various embodiments of the toggle.

FIG. 21 illustrates a method for deploying the arteriotomy device in across-section of a lumen.

FIGS. 22 and 23 illustrate methods for deploying the retainers in across-section of a lumen.

FIGS. 24 and 25 illustrate a method for deploying the introductiondevice in a cross-section of a lumen.

FIG. 26 illustrates a method for deploying a guidewire in across-section of a lumen.

FIGS. 27-30 illustrate a method for deploying the introduction device ina cross-section of a lumen.

FIG. 31 illustrates a method for deploying a guidewire in across-section of a lumen.

FIG. 32 illustrates a portion of an arteriotomized lumen.

FIG. 33 illustrates section A-A of FIG. 28.

FIGS. 34-36 illustrate a method for deploying a tensioner in asee-through portion of lumen wall.

FIGS. 37-40 illustrate methods for deploying various embodiments of thepressure clip in a cross-section of a lumen.

FIG. 41 illustrates a method of using a suture on a portion of anarteriotomized lumen.

FIG. 42 illustrates section B-B of FIG. 41 with the out-of-sectionsuture.

FIG. 43 illustrates a method of using pledgets on a portion of anarteriotomized lumen.

FIG. 44 illustrates section C-C of FIG. 43.

FIG. 45 illustrates an embodiment of the toggle deployment device in afirst configuration.

FIG. 46 is a close-up view of FIG. 45.

FIG. 47 illustrates an embodiment of the toggle deployment device in asecond configuration.

FIG. 48 is a close-up view of FIG. 47.

FIG. 49 illustrates a method of using the toggle deployment device in across-section of a lumen.

FIG. 50 illustrates FIG. 49 with a portion of the toggle deploymentdevice shown in section D-D.

FIG. 51 illustrates a method of using the toggle deployment device in across-section of a lumen.

FIG. 52 illustrates FIG. 51 with a portion of the toggle deploymentdevice shown in section E-E.

FIGS. 53-55 illustrate a method of using the toggle deployment device ina cross-section of a lumen.

FIG. 56 is a close-up view of FIG. 55.

FIG. 57 illustrates an embodiment of a deployed toggle in across-section of a lumen.

FIG. 58 is a close-up view of FIG. 59.

FIGS. 59-61 illustrate a method for deploying a toggle in across-section of a lumen.

FIG. 62 is a close-up view of FIG. 61.

FIG. 63 illustrates a method for deploying a toggle in a cross-sectionof a lumen.

FIGS. 64-66 shown, in cross-section, a method for deploying theguidewire through an arteriotomy.

FIGS. 67 and 68 illustrate a method for attaching guidewire to theanchor.

DETAILED DESCRIPTION

FIGS. 1 through 3 illustrate a device for accessing a biological lumen,such as an arteriotomy device 2. The arteriotomy device 2 can have adelivery guide 4. The delivery guide 4 can be slidably attached to ananchor 6. The anchor 6 can be rigid, flexible or combinations thereof.The anchor 6 can be resilient, deformable or combinations thereof. Theanchor 6 can be retractable and extendable from the delivery guide 4.The delivery guide 4 can have an introducer lumen 8. The introducerlumen 8 can have an introducer lumen exit port 10. The introducer lumenexit port 10 can be on the surface of the delivery guide 4.

The anchor 6 can have an anchor angle section 12. The anchor 6 can havean anchor extension section 14, for example a guide eye sheath or anattachable guidewire. The anchor extension section 14 can extend fromthe anchor angle section 12. The anchor extension section 14 can beseparate from and attached to, or integral with, the anchor anglesection 12.

The anchor angle section 12 can have an anchor angle first sub-section16, an anchor bend 20 and an anchor angle second sub-section 18. Theanchor angle first and/or second sub-sections 16 and/or 18 can be partof the anchor bend 20. The anchor bend 20 can have a sharp or gradualcurve. The radius of curvature for the anchor bend 20 can be from about0.1 mm (0.004 in.) to about 2.0 mm (0.079 in.).

The anchor angle first sub-section 16 can have an anchor angle firstsub-section diameter 22 from about 0.38 mm (0.015 in.) to about 1.0 mm(0.039 in.), for example about 0.71 mm (0.028 in.). The anchor anglesecond sub-section 18 can have an anchor angle second sub-sectiondiameter 24 from about 0.38 mm (0.015 in.) to about 1.0 mm (0.039 in.),for example about 0.71 mm (0.028 in.).

The anchor angle first sub-section 16 can have a delivery longitudinalaxis 26. The anchor angle second sub-section 18 can have an anchorlongitudinal axis 28. The intersection of the delivery longitudinal axis26 and the anchor longitudinal axis 28 can be an anchoring angle 30. Theanchoring angle 30 can be from about 20° to about 90°, more narrowlyfrom about 30° to about 60°, for example about 45°.

Any or all elements of the arteriotomy device 2 or other devices orapparatuses described herein can be made from, for example, a single ormultiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol),cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin,Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.),molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosedin International Pub. No. WO 03/082363 A2, published 9 Oct. 2003, whichis herein incorporated by reference in its entirety), tungsten-rheniumalloys, for example; as disclosed in International Pub. No. WO03/082363, polymers such as polyester (e.g., DACRON® from E. I. Du Pontde Nemours and Company, Wilmington, Del.), polypropylene,polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether etherketone (PEEK), nylon, polyether-block co-polyamide polymers (e.g.,PEBAX® from ATOFINA, Paris, France), aliphatic polyether polyurethanes(e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, Mass.),polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinatedethylene propylene (FEP), absorbable or resorbable polymers such aspolyglycolic acid (PGA), polylactic acid (PLA), polydioxanone, andpseudo-polyamino tyrosine-based acids, extruded collagen, silicone,zinc, echogenic, radioactive, radiopaque materials or combinationsthereof. Examples of radiopaque materials are barium sulfate, zincoxide, titanium, stainless steel, nickel-titanium alloys, tantalum andgold.

Any or all elements of the arteriotomy device 2, including supplementalclosure devices, such as tensioners, clips, toggles, sutures, or otherdevices or apparatuses described herein can be or have a matrix for cellingrowth or used with a fabric, for example a covering (not shown) thatacts as a matrix for cell ingrowth. The matrix and/or fabric can be, forexample, polyester (e.g., DACRON® from E. I. du Pont de Nemours andCompany, Wilmington, Del.), polypropylene, PTFE, ePTFE, nylon, extrudedcollagen, silicone or combinations thereof.

The elements of the arteriotomy device 2 and/or the fabric can be filledand/or coated with an agent delivery matrix known to one having ordinaryskill in the art and/or a therapeutic and/or diagnostic agent. Theagents within these matrices can include radioactive materials;radiopaque materials; cytogenic agents; cytotoxic agents; cytostaticagents; thrombogenic agents, for example polyurethane, cellulose acetatepolymer mixed with bismuth trioxide, and ethylene vinyl alcohol;lubricious, hydrophilic materials; phosphor cholene; anti-inflammatoryagents, for example non-steroidal anti-inflammatories (NSAIDs) such ascyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, forexample ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, forexample ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamicacid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., WhitehouseStation, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®,from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP)inhibitors (e.g., tetracycline and tetracycline derivatives) that actearly within the pathways of an inflammatory response. Examples of otheragents are provided in Walton et al, Inhibition of Prostoglandin E₂Synthesis in Abdominal Aortic Aneurysms, Circulation, Jul. 6, 1999,48-54; Tambiah et al, Provocation of Experimental Aortic InflammationMediators and Chlamydia Pneumoniae, Brit. J. Surgery 88 (7), 935-940;Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and ItsEffect on Inflammation and Proteolysis, Brit. J. Surgery 86 (6),771-775; Xu et al, Sp1 Increases Expression of Cyclooxygenase-2 inHypoxic Vascular Endothelium, J. Biological Chemistry 275 (32)24583-24589; and Pyo et al, Targeted Gene Disruption of MatrixMetalloproteinase-9 (Gelatinase B) Suppresses Development ofExperimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105(11), 1641-1649 which are all incorporated by reference in theirentireties.

FIG. 4 illustrates that the anchor angle section 12 and the anchorextension section 14 can have a flexible elongated element. The flexibleelongated element can be resilient and/or deformable. The flexibleelongated element can have an integral, or multiple separate and fixedlyattached, wound wire 32. The anchor angle section 12 can be in a sheath34. FIG. 5 illustrates that the anchor angle section 12 can have a wirecoating 36, for example a lubricious coating and/or a coating made fromurethane.

FIGS. 6 and 7 illustrate that the arteriotomy device 2 can have anintroduction device 38. The introduction device 38 can be slidablyattached to the introducer lumen 8. The introduction device 38 can havea hollow needle (as shown in FIG. 6). The introduction device 38 canhave a solid needle (as shown in FIG. 7). The introduction device 38 canhave a guidewire.

The introduction device 38 can have an introduction longitudinal axis40. The intersection of the introduction longitudinal axis 40 and theanchor longitudinal axis 28 can be an introduction angle 42. Theintroduction angle 42 can be less than or equal to about 19°, morenarrowly less than or equal to about 15°, yet more narrowly from about5° to about 10°, for example about ° 10.

The introduction device 38 can have an introduction device diameter 44.The introduction device diameter 44 can be from about 0.25 mm (0.010in.) to about 1.0 mm (0.039 in.), for example about 0.56 mm (0.022 in.).

FIGS. 8 and 9 illustrate that the arteriotomy device 2 can be configuredso that the introduction device 38 can be deployed from the anchor 6.The anchor 6 can have an introduction device port 46. The introductiondevice 38 can be a hollow needle (as shown in FIG. 8). When fullydeployed, the introduction device 38 can contact the introducer lumenexit port 10. The introduction device 38 can be a channel between theintroducer lumen 8 and the anchor 6. The anchor 6 can have a port (notshown) configured to communicate with the biological lumen and theintroduction device 38. The introduction device 38 can be a solid needle(as shown in FIG. 9).

FIG. 10 illustrates that a lumenal retainer 48 can have a firstretracted configuration. The lumenal retainer 48 can be seated in alumenal retainer port 50. The lumenal retainer port 50 can be in theanchor 6. The lumenal retainer 48 can be a wire, scaffold or stent—forexample made from a deformable or resilient material, such as a shapememory alloy—an inflatable balloon, or combinations thereof.Intralumenal inflatable balloons, such as those inflated with salinesolution or carbon dioxide, are known to those having ordinary skill inthe art. The lumenal retainer 48 can extend into the delivery guide 4.

FIGS. 11 and 12 illustrate that the lumenal retainer 48 can have asecond deployed configuration. FIG. 11 shows that the lumenal retainer48 can be a wire or balloon. FIG. 12 shows that the lumenal retainer 48can be a wire. In the deployed configuration, the lumenal retainer 48can deploy away from the lumenal retainer port. The lumenal retainer 48can have a lumenal retainer deployed diameter 52. The lumenal retainerdeployed diameter 52 can be from about 2.54 mm (0.100 in.) to about 10.2mm (0.400 in.), for example about 6.35 mm (0.250 in.).

FIG. 13 illustrates that the arteriotomy device 2 can have an entry wallretainer port 54. The entry wall retainer port 54 can be at or near theanchor bend 20. The entry wall retainer port 54 can be at or near theanchor angle first sub-section 16. The entry wall retainer port 54 canbe in fluid communication with a sensor or port (not shown) on or nearthe delivery guide 4 of the arteriotomy device 2.

FIG. 14 illustrates that an entry wall retainer 56 can be deployedthrough the entry wall retainer port 54. The entry wall retainer 56 canhave a first retracted configuration (as shown in FIG. 13). The entrywall retainer 56 can have a second deployed configuration (as shown inFIG. 14).

FIGS. 15 through 20 illustrate various supplemental closure devices. Thesupplemental closure devices can be completely or partiallybioabsorbable, bioresorbable, bioadsorbable or combinations thereof. Thesupplemental closure devices can be made from homografts, heterograftsor combinations thereof. The supplemental closure devices can be madefrom autografts, allografts or combinations thereof.

FIG. 15 illustrates a tensioner 58. The tensioner 58 can be resilient,deformable, or combinations thereof. The tensioner 58 can have atensioner longitudinal axis 60. The tensioner 58 can have a resilientelement, such as a spring, for example a tensioner head 62. Thetensioner head 62 can have a tensioner first shoulder 64. The tensionerhead 62 can have a tensioner second shoulder 66. The tensioner first andsecond shoulders 64 and 66 can rotatably attached to a separate orintegral tensioner first leg 68 and a separate or integral tensionersecond leg 70, respectively. The tensioner first and second legs 68 and70 can attach to tensioner first and second feet 72 and 74,respectively.

The tensioner legs 68 and 70 can have tensioner leg diameters 76. Thetensioner leg diameters 76 can be from about 0.1 mm (0.005 in.) to about0.76 mm (0.030 in.), for example about 0.38 mm (0.015 in.). Thetensioner first and second legs 68 and 70 can have a tensioner inter-legouter diameter 78. The tensioner inter-leg outer diameter 78 can be fromabout 1.3 mm (0.050 in.) to about 5.08 mm (0.200 in.), for example about4.06 mm (0.160 in.). The tensioner shoulders 64 and/or 66 and/or thetensioner feet 72 and/or 74 can extend to a greater radius from thetensioner longitudinal axis 60 than their respective tensioner inter-legradius.

FIG. 16 illustrates a tensioner first strut 80 that can attach to thetensioner first leg 68 and the tensioner second leg 70. The tensionerfirst leg 68 can be resilient, deformable or combinations thereof. Atensioner second strut 82 can attach to the tensioner first leg 68 andthe tensioner second leg 70. The tensioner second leg 70 can beresilient and/or deformable. The tensioner 58 can have no tensioner head62. The tensioner 58 can have more than two tensioner struts 80 and 82.

FIG. 17 illustrates a pressure clip 84. The pressure clip 84 can beresilient. The pressure clip 84 can be deformable. The pressure clip 84can have a pressure clip longitudinal axis 86. The pressure clip 84 canhave a pressure clip head 88. The pressure clip head 88 can be rotatablyattached to a separate or integral pressure clip first leg 90. Thepressure clip head 88 can be rotatably attached to a separate orintegral pressure clip second leg 92. The pressure clip can have apressure clip first end 94 and a pressure clip second end 96. Thepressure clip first leg 90 can terminate in the pressure clip first end94. The pressure clip second leg 92 can terminate in the pressure clipsecond end 96. The pressure clip first leg 90 and/or the pressure clipsecond leg 92 can be biased toward the pressure clip longitudinal axis86.

FIG. 18 illustrates the pressure clip 84 that can have a pressure clipsheath 98 slidably attached to the pressure clip second leg 92. Thepressure clip first and/or second ends 94 and/or 96 can be pressuredissipaters, such as flat and/or curved portions, for example circularloops. The pressure clip first and/or second ends 94 and/or 96 can beresilient and/or deformable. The pressure clip first leg 90 can berotatably attached to the pressure clip second leg 92. The pressure clipfirst leg 90 can be attached to the pressure clip second leg 92 via arotatable, and/or deformable, and/or flexural joint in the pressure cliphead 88.

FIG. 19 illustrates a toggle 100. The toggle 100 can have a toggle firstend 102. The toggle 100 can have a toggle second end 104. The togglefirst and/or second ends 102 and/or 104 can be bars, dowels, rods,beams, or combinations thereof. The toggle 100 can have a filament 106.The filament 106 can be fixedly attached at a filament first end 107 tothe toggle first end 102. The filament 106 can be fixedly attached at afilament second end 109 to the toggle second end 104. The filament 106can be resilient or deformable. The filament 106 can be substantiallyflexible.

FIG. 20 illustrates the toggle 100 that can have the filament 106 thatcan be slidably attached to the toggle second end 104 at a hole 108. Thefilament 106 can frictionally fit the hole 108. The filament 106 canhave no pawls 110 (not shown in FIG. 20). The filament 106 caninterference fit the hole 108. The filament 106 can have one or morepawls 110. The hole 108 can have one or more notches 112. The notches112 can be internal to the hole 108. The notches 112 and the pawls 110can be configured to allow the toggle second end 104 to slide toward thetoggle first end 102. The notches 112 and the pawls 110 can beconfigured to provide an interference fit when the toggle second end 104is attempted to be moved away from the toggle first end 102.

Method of Manufacture

The elements of the arteriotomy device 2, including the supplementalclosure devices, can be directly attached by, for example, melting,screwing, gluing, welding or use of an interference fit or pressure fitsuch as crimping, snapping, or combining methods thereof. The elementscan be integrated, for example, molding, die cutting, laser cutting,electrical discharge machining (EDM) or stamping from a single piece ormaterial. Any other methods can be used as known to those havingordinary skill in the art.

Integrated parts can be made from pre-formed resilient materials, forexample resilient alloys (e.g., Nitinol, ELGILOY®) that are preformedand biased into the post-deployment shape and then compressed into thedeployment shape as known to those having ordinary skill in the art.

Any elements of the arteriotomy device 2, including the supplementalclosure devices, or the arteriotomy device 2, including the supplementalclosure devices, as a whole after assembly, can be coated bydip-coating, brush-coating or spray-coating methods known to one havingordinary skill in the art. For example, these methods can be used tocoat the wound wire 32 with the wire coating 36 can be spray coated,dip-coated or brushed onto the wire 32.

One example of a method used to coat a medical device for vascular useis provided in U.S. Pat. No. 6,358,556 by Ding et al. and herebyincorporated by reference in its entirety. Time release coating methodsknown to one having ordinary skill in the art can also be used to delaythe release of an agent in the coating, for example the coatings on thesupplemental closure devices.

The supplemental closure devices can be covered with a fabric, forexample polyester (e.g., DACRON® from E. I. du Pont de Nemours andCompany, Wilmington, Del.), polypropylene, PTFE, ePTFE, nylon, extrudedcollagen, silicone or combinations thereof. Methods of covering animplantable device with fabric are known to those having ordinary skillin the art.

Method of Use

FIG. 21 illustrates a method of inserting the anchor 6 into a biologicallumen 114, for example a blood vessel, such as a femoral artery. Thebiological lumen 114 can have a lumen wall 116 and a lumen wall surface118. The anchor 6 can be inserted into the biological lumen 114 using aSeldinger technique, modified Seldinger technique, or other method knownto one having ordinary skill in the art. The anchor 6 can create a firstarteriotomy 120. The anchor 6 can be inserted into the lumen 114 so thatthe anchor angle second sub-section 18 can be substantially parallelwith the lumen wall surface 118. The anchor 6 can be inserted into thelumen 114 so that the anchor angle second sub-section 18 can besubstantially in contact with the lumen wall surface 118.

FIG. 22 illustrates a method of deploying, as shown by arrow, thelumenal retainer 48 from the first retracted configuration to the seconddeployed configuration. The lumenal retainer 48 can be deployed byextending a wire, scaffold or stent, or by inflating a balloon. When thelumenal retainer 48 is deployed, the anchor angle second sub-section 18can be made substantially parallel with the lumen wall surface 118. Whenthe lumenal retainer 48 is deployed, the anchor angle second sub-section18 can be made to be substantially in contact with the lumen wallsurface 118.

FIG. 23 illustrates a method of deploying, as shown by arrow 122, theentry wall retainer 56 from the first retracted configuration to thesecond deployed configuration. When the lumenal retainer is in thesecond deployed configuration, the lumenal retainer 48 can besubstantially parallel with the lumen wall surface 118. When the lumenalretainer is in the second deployed configuration, the lumenal retainer48 can be substantially in contact with the lumen wall surface 118.

A proximal force, as shown by arrow 124, can be applied to the anchor 6,for example by being applied to the delivery guide 4. When the proximalforce is applied, the anchor angle second sub-section 18 can be madesubstantially parallel with the lumen wall surface 118. When theproximal force is applied, the anchor angle second sub-section 18 can bemade to be substantially in contact with the lumen wall surface 118.

FIGS. 24 and 25 illustrate a method for deploying the introductiondevice 38. The introduction device 38 can egress from the introducerlumen 8 and the introducer lumen exit port 10. As shown in FIG. 24, theintroduction device 38 can be pushed, as shown by arrow, into andthrough the lumen wall 116. The introduction device 38 can form a secondarteriotomy 128. As shown in FIG. 25, the introduction device 38 can bepushed, as shown by arrow, adjacent to or through the anchor 6. Theanchor 6 can be configured to have ports suitable to allow theintroduction device 38 to pass through the anchor 6. A tip of theintroduction device 38 can enter the lumen 114.

The introduction device 38 can pass through an introduction run 132 andan introduction rise 134. The introduction run 132 can be the componentof the length of the introduction device 38 in the lumen wall 116 thatis parallel to the lumen wall 116. The introduction run 132 can be thecomponent of the length parallel to the lumen wall 116 between theopening of the second arteriotomy 128 on the outside of the lumen wall116 and the opening of the second arteriotomy 128 on the inside lumenwall surface 118. The introduction run 132 can be from about 0.10 cm(0.010 in.) to about 3.810 cm (1.500 in.), for example about 0.64 cm(0.25 in.).

The introduction rise 134 can be the component of the length of theintroduction device 38 in the lumen wall 116 that is perpendicular tothe lumen wall 116. The introduction rise 134 can be the component ofthe length perpendicular to the lumen wall 116 between the opening ofthe second arteriotomy 128 on the outside of the lumen wall 116 and theopening of the second arteriotomy 128 on the inside lumen wall surface118. The introduction rise 134 can be from about 0.51 mm (0.020 in.) toabout 5.08 mm (0.200 in.), for example about 1.0 mm (0.040 in.). Anintroduction slope can be the ratio of the introduction rise 134 to theintroduction run 132. The introduction slope can be from about ½ toabout 1/40 or less, for example about ⅙, also for example about ⅓. Theintroduction slope can be, for examples, equal to or less than about ½or ⅓, more narrowly equal to or less than about ⅓ or ¼, yet morenarrowly equal to or less than about ⅕ or ⅙, even still more narrowlythan about equal to or less than about 1/10.

The introduction rise 134 and the introduction run 132 can be componentsof an introduction vector. The introduction run 132 can be the componentof the introduction vector parallel to the lumen wall 116. Theintroduction rise 134 can be the component of the introduction vectorperpendicular to the lumen wall 116. The introduction vector can be avector from an outer opening 136 to an inner opening 138. The outeropening 136 can be a temporary or permanent opening on the outside ofthe lumen wall 116 formed by the introduction device 38. The inneropening 138 can be a temporary or permanent opening on the inside of thevessel wall.

FIG. 26 illustrates that the introduction device 38, for example ahollow needle, can act as a pathway for a lumenal tool, for exampletools such as a guidewire 168, to be deployed, as shown by arrow, intothe lumen 114. The introduction device 38, for example a solid needle,can be removed from the second arteriotomy 128 and the lumenal tool canbe deployed through, for example, the introducer lumen exit port 10, andthe second arteriotomy 128. The introduction device 38 can be thelumenal tool, for example a guidewire. The introduction device 38 can befurther deployed and used as a lumenal tool after passing through thelumen wall 116.

FIGS. 27 through 30 illustrates a method of deploying the introductiondevice 38 that can have a pre-formed bend. As shown in FIG. 27, thearteriotomy device 2 can be configured to deploy the introduction device38 at the introduction angle 42 from about 0° to about 5°, for exampleabout 0°.

As shown in FIG. 28, the introduction device 38 can be pushed, as shownby arrow, through the lumen wall 116. The introduction device 38 cancleave a plane in the lumen wall 116. The plane can be substantiallyparallel with the lumen wall surface 118. The introduction device 38 canbe adjacent to the adventitia in a blood vessel. The introduction device38 can be advanced along the subintimal or submedial cleavage plane in ablood vessel. Once the lumen wall has been cleaved, a subintimalangioplasty can be performed as known to one having ordinary skill inthe art. Once the lumen wall has been cleaved, a remote endarterectomycan be performed as known to one having ordinary skill in the art. Bentand straight introduction devices 38 can be swapped during use toselectively cleave the lumen wall 116. Tools, such as guidewires, can beinserted through hollow introduction devices 38 to selectively cleavethe lumen wall 116.

As shown in FIG. 29, when the bend in the introduction device 38 movesinto the lumen wall 116, the introduction device 38 can rotate, as shownby arrow, toward the biological lumen 114. As shown in FIG. 30, the bendin the introduction device 38 can continue to rotate the introductiondevice 38 toward the biological lumen 114. As described infra, theintroduction device 38 can enter the lumen 114. FIG. 31 illustrates thatthe introduction device 38 that can have the bend can act as a pathwayfor a lumenal tool, as described infra.

An introducer sheath can be inserted over the guidewire 168 and/or theintroduction device 38. The introducer sheath can be less than about 22French (7.3 mm, 0.29 in. diameter) or less than the diameter of thelumen to which the introducer sheath is introduced. The introducersheath can be, for examples, about 6 French (2.3 mm, 0.092 in.diameter), and about 8 French (2.67 mm, 0.105 in. diameter). Theintroducer sheath can be known to one having ordinary skill in the art,for example the introducer sheath described in U.S. Pat. No. 5,183,464to Dubrul, et al.

The introducer sheath can be inserted into the second arteriotomy 128.The introducer sheath can expand the second arteriotomy 128 to aworkable size. The introducer sheath can be inserted into the secondarteriotomy 128 before and/or after and/or concurrently with thesupplemental closure device is deployed and/or other closure method isused.

FIGS. 32 and 33 illustrate an exemplary biological lumen 114 after thearteriotomy device 2 has been deployed to, and removed from, thebiological lumen 114. The biological lumen 114 can have the first andsecond arteriotomies 120 and 128. The biological lumen 114 can have asecond arteriotomy 128. The biological lumen 114 can have a first web140 on one side of the arteriotomy (shown for the second arteriotomy128), and a second web 142 on the opposite side of the arteriotomy 120or 128. The natural pressure, shown by arrows, from the first and secondwebs 140 and 142 can self-seal the arteriotomy 120 or 128.

One or more supplemental closure devices can be deployed to the firstand/or second arteriotomies 120 and/or 128. The supplemental closuredevices can provide a force or restraint to aid hemostasis. Thesupplemental closure devices can be permanently or temporarily deployed.The supplemental closure devices can biodissolve after hemostasis isachieved and/or after the relevant arteriotomy 120 or 128 issubstantially or completely healed. The force from the supplementalclosure device can be maintained from about 15 minutes to about 24 hoursor more, for example about 120 minutes.

FIG. 34 illustrates a tensioner 58 in a compressed configuration.Compressive forces, shown by arrows, can compress the tensioner firstand second legs 68 and 70. In a compressed configuration, the tensionerinter-leg outer diameter 78 can be from about 0.51 mm (0.020 in.) toabout 2.54 mm (0.100 in.), for example about 1.5 mm (0.060 in.).

FIGS. 35 and 36 illustrate a method of deploying the tensioner 58. Asshown in FIG. 35, the tensioner 58 can be in a compressed configuration.The tensioner 58 can be exposed to the compressive forces, as shown byarrows 144. The compressive forces can be applied by a retractablesheath, clamps, other methods known to one having ordinary skill in theart, or combinations thereof. A deployment force, shown by arrow 146,can deploy the tensioner 58 into the arteriotomy 120 or 128.

The arteriotomy 120 or 128 can have an arteriotomy diameter 148. Thearteriotomy diameter 148 can be from about 0.5 mm (0.020 in.) to about400 mm (15 in.), yet a narrower range from about 1.0 mm (0.040 in.) toabout 10.2 mm (0.400 in.), for example about 2.54 mm (0.100 in.). Whenin the compressed configuration, the tensioner inter-leg outer diameter78 can be smaller than the arteriotomy diameter 148. The tensioner firstand second shoulders 64 and 66 can be wide enough to interference fitwith the arteriotomy 120 or 128. The tensioner first and secondshoulders 64 and 66 can dissipate force on the lumen wall surface 118.

As shown in FIG. 36, the compressive forces can be removed from thetensioner 58. The tensioner first and second leg 68 and 70 can expand,as shown by arrows. The tensioner 58 can force the arteriotomy 120 or128 into a substantially or completely flat and/or closed and/orstretched configuration. The walls of the arteriotomy 120 or 128 cancome into close contact.

The arteriotomy 120 or 128 can have an arteriotomy width 150 and anarteriotomy height 152. The arteriotomy width 150 can be about half thecircumference of the arteriotomy 120 or 128. The arteriotomy width 150can be from about 1.0 mm (0.040 in.) to about 10.2 mm (0.400 in.), forexample about 4.06 mm (0.160 in.).

The arteriotomy height 152 can be about the tensioner leg diameter 76.The arteriotomy height 152 can be less than about 0.51 mm (0.020 in.),more narrowly, less than about 0.38 mm (0.015 in.). The arteriotomyheight 152 can be from about 0.25 mm (0.010 in.) to about 1.3 mm. (0.050in.), for example about 0.38 mm (0.015 in.). The arteriotomy height 152can be small enough to enable cell growth, blood clotting, acousticsealing, heat sealing, gluing, enhanced self-sealing and combinationsthereof across the arteriotomy 120 or 128.

The tensioner first and second shoulders 64 and 66 can be wide enough tointerference fit with the arteriotomy 120 or 128. The tensioner firstand second feet 72 and 74 can be wide enough to interference fit withthe arteriotomy 120 or 128. The tensioner first and second feet 72 and74 can dissipate force on the lumen wall surface 118.

The arteriotomy 120 or 128 can be plugged, and/or packed, and/ortamponed before, and/or concurrent with, and/or after using any of anyof the supplemental closure devices infra and/or supra, the self-sealingclosure method, or combinations thereof. The plug, pack, tampon, orcombinations thereof (not shown) can be made from gelfoam, collagen,other implantable and biocompatible tampon materials known to thosehaving ordinary skill in the art, or combinations thereof.

FIGS. 37 through 40 illustrate deploying the pressure clip 84 to thearteriotomy 120 or 128. FIG. 37 illustrates extending, and/or thinning,and/or straightening, and/or tensioning the pressure clip second end 96.The pressure clip sheath 98 can be translated, as shown by arrow, alongthe pressure clip second leg 92 and onto the pressure clip second end96. The pressure clip 84 can be deployed to the arteriotomy after thepressure clip second end 96 is extended, and/or thinned, and/orstraightened, and/or tensioned.

As shown in FIG. 38, the pressure clip second leg 92 can be rotated withrespect to the pressure clip head 88, so that the pressure clip secondleg 92 and the pressure clip head 88 are substantially aligned. Thepressure clip second leg 92 can be deployed, as shown by the arrow,through the first arteriotomy 120. The pressure clip second leg 92 canbe deployed through the lumen wall 116 (e.g., if there is no existingfirst arteriotomy 120, if the first arteriotomy 120 is not suitablylocated with respect to the second arteriotomy 128).

FIG. 39 illustrates contracting, and/or widening, and/or releasingand/or relaxing the pressure clip second end 96. The pressure clipsheath 98 can be translated, as shown by arrow, along the pressure clipsecond leg 92 and off of the pressure clip second end 96. The pressureclip second end 96 can be contracted, and/or widened, and/or releasedand/or relaxed after the pressure clip 84 is deployed to thearteriotomy.

As shown in FIG. 40, after the pressure clip second leg 92 is deployedthrough the first arteriotomy 120, the pressure clip second leg 92 canbe released or deformed so as to rotate with respect to the pressureclip head 88. The pressure clip head 88 can seat in the firstarteriotomy 120. The pressure clip first and second legs 90 and 92 canapply force, as shown by arrows, to the first and second webs 140 and142, respectively.

FIGS. 41 and 42 illustrate a method of deploying a stitch 154surrounding and/or through the arteriotomy 120 or 128. The stitch 154can be tightened to apply additional pressure to the arteriotomy 120 or128. The stitch 154 can have a knot 156, or other tying configuration ordevice, for example a pledget or clamp.

FIGS. 43 and 44 illustrate a method of deploying the filament 106adjacent to and/or through the arteriotomy 120 or 128. The filament 106can be attached to a first pledget 158 a by a first knot 156 a or othertying configuration or device. The filament 106 can be attached to asecond pledget 158 b by a second knot 156 b or other tying configurationor device. The first and second pledgets 158 a and 158 b can be otherpressure diffusers known to one having ordinary skill in the art, suchas the toggles 100 described infra and supra.

FIGS. 45 and 46 illustrate a toggle deployment device 159 that can be ina first retracted configuration. The toggle deployment device 159 canhave a pressure check port 160. The pressure check port 160 can be influid communication with a sensor or port on or near the handle (notshown) of the toggle deployment device 159, such as an external lumenwhere blood flow can be observed, for example from flow from the end ofan external tube or port and/or through a transparent or translucentwindow. The pressure check port 160 can facilitate deployment of thetoggle deployment device 159 to a location where the pressure check port160 is introduced to pressure, for example when the pressure check port160 enters the biological lumen 114. The sensor or port on or near thehandle of the toggle deployment device 159 will signal that the pressurecheck port 160 has been placed into the biological lumen 114 (e.g., bydisplaying a small amount of blood flow). The pressure check port 160can be deployed into the biological lumen 114 and then withdrawn fromthe biological lumen 114 to the point, where the lumen wall 116 juststops the pressure in the pressure check port 160. The entry wallretainer port 54 can additionally perform the function as describedherein for the pressure check port 160. The toggle deployment device 159can have a delivery needle port 161.

FIGS. 47 and 48 illustrate the toggle deployment device 159 that can bein a second delivery configuration. A delivery needle 162 can beslidably attached to the toggle deployment device 159. The deliveryneedle 162 can egress from the delivery needle port 161 when the toggledeployment device 159 is in the second delivery configuration.

FIGS. 49 and 50 illustrate that the toggle deployment device 159 can bedeployed into the arteriotomy 120 or 128 at a location where thepressure check port 160 can be located in the biological lumen 114. Thedelivery needle port 161 can be in, or adjacent to, the lumen wall 116.

FIGS. 51 and 52 illustrate that the toggle deployment device 159 can beplaced in the second delivery configuration. If the delivery needle portis in, or adjacent to, the lumen wall 116 when the toggle deploymentdevice 159 is placed in the second delivery configuration, the deliveryneedle 162 can enter the lumen wall 116. For example, the deliveryneedle 162 can enter the second web 142. The delivery needle 162 canexit the second web 142 and enter, as shown by arrows, the biologicallumen 114.

FIG. 53 illustrates that a pusher 164 can be slidably attached to thedelivery needle 162. The delivery needle 162 can have a needle tip port166. The toggle 100 can be in the delivery needle 162. The toggle 100can be configured in the delivery needle 162 such that the toggle firstend 102 can be located on the needle tip port 166 side of the pusher164.

FIG. 54 illustrates that the pusher 164 can be moved, as shown by arrow,toward the needle tip port 166. The delivery needle 162 can be movedback relative to the pusher 164, the pusher 164 can be moved forwardrelative to the delivery needle 162, or combinations thereof. The pusher164 can push the toggle first end 102 out of the delivery needle 162.The pusher 164 can push the toggle first end 102 into the biologicallumen 114.

FIGS. 55 and 56 illustrate that the toggle deployment device 159 can bein a first retracted configuration after deploying the toggle first end102 into the biological lumen 114. When the delivery needle 162 retractsinto the toggle deployment device 159, the toggle second end 104 can bein the toggle deployment device 159. The filament 106 can extend thoughthe delivery needle port 161.

FIGS. 57 and 58 illustrate that the toggle 100 can be deployed acrossthe lumen wall. When the toggle deployment device 159 is removed fromthe arteriotomy, the toggle second end 104 can deploy on the outside ofthe lumen wall 116 from the delivery needle port 161. The toggle firstend 102 can form an interference fit with the lumen wall surface 118.The toggle second end 104 can form an interference fit with the outsideof the lumen wall 116 or the surrounding tissue, such as subcutaneoustissue. The toggle second end 104 can be slidably translated along thefilament 106 toward the lumen wall 116, for example for the toggle 100illustrated in FIG. 20. The length of the filament 106 on the oppositeside of toggle second end 104 from the toggle first end 102 can be cut,snapped, torn or otherwise removed.

FIGS. 59 through 63 illustrate a method for deploying the toggle 100.The delivery needle 162 can egress, as shown by arrow, from a toggledeployment delivery port 163. The toggle deployment delivery port 163can be in the delivery guide 4. The delivery needle 162 can be advancedtoward the lumen 114.

FIG. 60 illustrates that the delivery needle 162 can be deployed throughthe lumen wall. When the delivery needle 162 is deployed through thelumen wall 116, the delivery needle can intersect, or pass adjacent to,the second arteriotomy.

FIGS. 61 and 62 illustrate that the pusher 164 can be advanced, as shownby arrow, through the delivery needle 162. The toggle first end 102 canegress from the needle tip port 166. The toggle first end 102 can deployinto the lumen 114.

FIG. 63 illustrates that the delivery needle 162 can be retracted intothe delivery guide 4 and/or the filament 106 can be pulled taught, bothshown by arrow. The toggle first end 102 can form an interference fitwith the lumen wall surface 118. The toggle second end 104 (not shown inFIG. 63) can be slidably translated on the filament 106 down to, andform an interference fit with, the outside of the lumen wall 116. Thelength of the filament 106 on the opposite side of toggle second end 104from the toggle first end 102 can be cut, snapped, torn or otherwiseremoved.

FIG. 64 illustrates an introducer needle 165 that can have an endinserted, as shown by arrow, through the lumen wall 116 and into thelumen 114, for example by using the Seldinger technique. The introducerneedle 165 can be hollow and/or have a longitudinal channel. FIG. 65illustrates that the guidewire 168 can be deployed, shown by arrows,through the hollow and/or longitudinal channel of the introducer needle165.

FIG. 66 illustrates that the introducer needle 165 can be removed, asshown by arrow, from the lumen wall 116. The guidewire 168 can remainsubstantially in place. After the introducer needle 165 is removed, aportion of the guidewire 168 can be outside the lumen 114 and anotherportion of the guidewire 168 can be inside the lumen 114.

FIG. 67 illustrates a method of fixedly or slidably attaching theguidewire 168 to the anchor 6. A guidewire proximal end 170 can beplaced in proximity to an anchor distal end 172. The guidewire proximalend 170 can then be attached, as shown by arrows, to the anchor distalend 172. The guidewire proximal end 170 can be attached to the anchordistal end 172 while some or all of the guidewire 168 is in the lumen114. The guidewire proximal end 170 can be configured to snap-fit,interference fit, slidably attach or combinations thereof, to the anchor6. When the guidewire 168 is attached to the anchor 6, the guidewire 168can act as the anchor extension section 14 and/or the lumenal tool. FIG.68 illustrates the guidewire 168 attached to the anchor 6.

Where applicable, the methods described supra for deploying anysupplemental closure device can be used for deploying any of the othersupplementary deployment device. It is apparent to one skilled in theart that various changes and modifications can be made to thisdisclosure, and equivalents employed, without departing from the spiritand scope of the invention. Elements shown with any embodiment areexemplary for the specific embodiment and can be used on otherembodiments within this disclosure.

1-55. (canceled)
 56. A method comprising: introducing an introducer intotissue; and traversing the introducer through the tissue to form a tractin the tissue, wherein the tract includes at least one sloped region,and the tract self-seals.
 57. The method of claim 56, wherein the tissuecomprises a blood vessel.
 58. The method of claim 57, wherein the bloodvessel comprises a vessel wall defining a lumen, and traversing theintroducer through the tissue to form a tract in the tissue comprisestraversing the introducer through the vessel wall.
 59. The method ofclaim 58, wherein the vessel wall comprises intima, media, adventitia,or a combination thereof.
 60. The method of claim 57, wherein the bloodvessel comprises an artery.